Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Stress Urinary Incontinence.

NACompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

November 27, 2020

Primary Completion Date

December 30, 2023

Study Completion Date

December 30, 2023

Conditions
Urinary Incontinence,Stress
Interventions
DEVICE

Non-ablative vaginal Erbium YAG laser treatment

Laser therapy is performed using a 2940 nm VEL (SP Spectro, Fotona, Slovenia) with SMOOTH mode setting, which enables non-ablative, thermal-only operation. The parameters are selected based on extensive preclinical and clinical studies.

OTHER

PFE

PFE will be prescribed as it is already implemented in clinical practice (i.e. up to 2x 9 sessions with a pelvic floor physiotherapist of choice). Type of physiotherapy, number of completed sessions and duration of therapy will be recorded.

Trial Locations (1)

3000

UZ Leuven, Leuven

All Listed Sponsors
lead

Universitaire Ziekenhuizen KU Leuven

OTHER

NCT04643353 - Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Stress Urinary Incontinence. | Biotech Hunter | Biotech Hunter